Patient Empowerment and Risk-assessed Treatment to Improve Outcome in the Elderly After Onco-surgery

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Information

• Registration Number: NCT01278537
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The aims of this study are to investigate whether patient empowerment, including information and decision-aids adapted to the risk and the need of the elderly patient, can improve outcome in an evidence-based modular pathway in terms of

* shortened hospital stay by a reduced postoperative complication rate and

* quality of life in elderly patients compared to control patients receiving standard of care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Study Start: 2011-02
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

• Patients aged 65 years and older with abdominal, thoracical or urogenital cancer scheduled for surgery
• Offered patient information and written informed consent
• Confirmed cancer diagnosis via histology
• Mini Mental state > 23
• Life-expectance > 2 months

Exclusion Criteria

• Participation in another trial according to the German Drug Law 7 days to and 7 days after the operation during the study
• No informed consent
• Emergency patients
• Lacking willingness to save and hand out data within the study
• Accommodation in an institution due to an official or judicial order
• Concurrent malignancies
• Insufficient knowledge of the German language
• In case of the inclusion of a PERATECS - study patient in an adjuvant therapy study during the study period, the patient will be excluded from the PERATECS-study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empowerment, shared-decision making,	Information	Patients receive a booklet with informations. Assessment of health-related risk factors. Assessment of psychological and physical social support Delirium protection. Early mobilization.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	within the first month
Quality of life	within the first year

Secondary Outcome Measures

Name	Time	Method
Readmission rate	within the first three months
Short-term complications	within the first months
Overall mortality	within one year
Depression	within the first year
Stress	within the first month	Stress induced by postoperative pain, lack of mobilization and PONV.

Trial Locations

Locations (3)

Evangelisches Geriatriezentrum Berlin gGmbH; 🇩🇪 Berlin, Germany

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Department of Anaesthesiology, Hospital of the Ludwig - Maximilians - University of Munich; 🇩🇪 München, Germany